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NCT Number: NCT06819982

Autonomous At Home with Occupational Therapy Support and Assistive Devices

The aim of the AUDACE study is to evaluate the 'Bien chez Moi 2.0' programme, to assess how, for whom and why do assistive devices, integrated with occupational therapy support, enable older people to remain at home, and under what conditions? The study assesses the impact on areas such as the degree of autonomy, the extent to which life goals are taken into account, the feeling of security at home, the use of hospital emergency services and the postponement of definitive institutionalisation in a nursing home. The expected results of this study are to be able to robustly describe the impact of the 'Bien chez moi 2.0' programme in the areas listed above.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Background The BCM2.0 programme provides occupational therapy sessions and assistive devices to support older people who want to age in place. The investigators designed the AUDACE evaluation to improve understanding of the programme and its effectiveness, and to promote a favourable context for the professional empowerment of occupational therapists as primary care providers.

Methods The investigators involved home care occupational therapists at every stage of the protocol design to ensure that the tools, training, and organisational structures put in place for the evaluation could also form the basis of their routine practice, harmonising their practices, ethos and processes.

The investigators designed a realist mixed methods evaluation to answer the following question: "How, for whom and why do assistive devices, integrated with occupational therapy support, enable older people to remain at home, and under what conditions?" Interrelated components addressed different research sub-questions: (1a) To describe the evaluation population, interventions, and contexts: a descriptive quantitative study using baseline data from all BCM2.0 beneficiaries. (1b) To describe the frailty process in older people receiving the programme: a qualitative study using semi-structured individual interviews with a biographical dimension. (2) To explore the enrolment process: focus groups with occupational therapists, following a realist approach. (3) To assess effectiveness: a prospective cohort study with up to 12 months follow-up of all BCM2.0 beneficiaries. (4) To identify barriers and facilitators to implementation: multiple nested case study in five areas, using a realist approach. (5) To build a learning community to clarify ethical considerations: communities of practice meetings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • people aged 65 and over
  • living at home in the Walloon and Brussels regions
  • who are considered frail or at risk of frailty. The risk of frailty is defined as having at least one loss of intrinsic capacity measured by a trained occupational therapist using the ICOPE screening tool

Exclusion criteria

  • People benefiting from other AViQ autonomy programmes of this project are excluded

Treatment and study plan

BCM2.0

Other

The BCM2.0 programme provides occupational therapy sessions and assistive devices to support older people who want to age in place.

Primary outcomes

  1. COPM

    Time frame: At enrolment and six months follow up.

    Endpoints will be calculated as the within-subject difference in measurement between baseline and six-month follow-up in Canadian Occupational Performance Measure (COPM), assessing daily occupations of importance that people are unable to perform.

    Scale description:

    Canadian Occupational Performance Measure Range 1-10 Higher score = Better outcome

Secondary outcomes

  1. Short FES-I

    Time frame: At enrolment and six months follow up.

    Endpoint will be calculated as the within-subject difference in measurement between baseline and six-month follow-up for short FES-I (short Fall efficacy scale - international, measuring concern over the possibility of falling)

    Scale description:

    short Fall efficacy scale - international Range 7-28 Higher score = Worse outcome

  2. Health-related QoL

    Time frame: At enrolment and six months follow up.

    Endpoint will be calculated as the within-subject difference in measurement between baseline and six-month follow-up for EQ-5D-5L mapped to Belgian utility scores.

    Scale description:

    EQ-5D-5L Range: Below 0 to 1 Higher score = Better outcome

  3. Hospitalisation

    Time frame: At enrolment and six months follow up.

    Endpoint will be calculated as the within-subject difference in measurement between baseline and six-month follow-up for use of hospitalisation and institutionalisation in a nursing home (number of stay in the last six months).

    Scale description:

    Number of stay in hospital or nursing home Range: 0+ Higher score = Worse outcome

  4. Use of assistive devices

    Time frame: At enrolment and six months follow up.

    Endpoint will be calculated as the within-subject difference in measurement between baseline and six-month follow-up for use of assistive devices (binary response).

  5. Sense of security

    Time frame: At enrolment and six months follow up.

    Endpoint will be calculated as the within-subject difference in measurement between baseline and six-month follow-up for sense of security (on a 7-point Likert scale).

    Range: 1-7 Higher score = Better outcome

  6. Entry in nursing home

    Time frame: Any time within the first six months after enrolment.

    Days since enrolment when the person entered a nursing home.

    Analysed as a right censored variable. The event happening in a worse outcome. Death is treated as censoring.

  7. (I)ADL

    Time frame: At enrolment and at six month follow up.

    Endpoint will be calculated as the within-subject difference in measurement between baseline and six-month follow-up for ad-hoc questions on assistance received on(I)ADL domains.

    (Instrumental) Activities of Daily Living How many of 15 activities need help to be performed? Two scores: informal caregiver help, and professional caregiver help.

    Range: 0-15 Higher value = Worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Thérèse Van Durme

CONTACT

[email protected]

+32 (0)2 764 30 99

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

Autonome À Domicile Grâce À Un Appareil Connecté Et À Un Suivi Ergo

Acronym: AUDACE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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